皮疹与厄洛替尼治疗晚期非小细胞肺癌疗效相关性研究

The correlation between skin rash and the effi cacy of erlotinib in patients with advanced non-small cell lung cancer

背景与目的:厄洛替尼(erlotinib)是治疗非小细胞肺癌(non-small cell lung cancer,NSCLC)的一种靶向性抗肿瘤药物,皮疹是使用厄洛替尼的主要不良反应,本研究旨在探讨不同程度皮疹与厄洛替尼治疗晚期NSCLC疗效是否存在相关性。方法:对接受过1个周期以上含铂化疗方案失败的晚期NSCLC患者,每日口服150mg厄洛替尼直至疾病进展,将出现0、1～2、3度皮疹患者分为3组,观察出现不同程度皮疹的患者接受厄洛替尼治疗后的疗效和生存时间。采用Kaplan-Meier法分析比较各组间的生存率差异。结果:0度皮疹组共有3例,有效率为0(0/3),1～2度皮疹组有36例,有效率为22.2%(8/36),3度皮疹组有9例,有效率为88.8%(8/9),各皮疹组之间有效率差异具有统计学意义(P<0.001)。1～2度皮疹出现中位时间为7d,3度皮疹出现中位时间为21d。0、1～2和3度皮疹组的中位无进展时间分别为2、4和10个月,各组之间差异无统计学意义(P=0.067)。中位生存时间分别为5、6和23个月,各组之间差异亦无统计学意义(P=0.146)。0～2度和3度皮疹组中位无进展生存时间分别为3和10个月,2组之间差异有统计学意义(P=0.036);中位生存时间分别为6和23个月,2组之间差异无统计学意义(P=0.073)。结论:对于不同程度皮疹与厄洛替尼治疗晚期NSCLC有效率之间存在一定相关性,皮疹较重患者有效率较高,3度皮疹患者无进展生存时间长于其他患者。

Background and purpose： Erlotinih is a kind of targeted treatment drugs for non-small cell lung cancer. Skin rash is the major adverse effect of erlotinib. The aim of this study was to explore the relation of skin rash to the efficacy of erlotinib in patients with advanced non-small cell lung cancer. Methods： Patients with non-small cell lung cancer who had been previously treated with at least one course of platinum based chemotherapy received 150 mg oral doses of erlotinib once daily until disease progression. Response rate, progression free survival and overall survival were analyzed in the different severity skin rash group. Kaplan-Meier method was used to analyze the survival rate. Results： The response rate was 0, 22.2% and 88.8% in the grade 0, 1-2 and 3 skin rash groups （P〈0.001）. The median time of occurrence of skin rash was 7 and 21 days in the grade 1-2 and 3 skin rash groups, respectively. The median progression-free survival was 2, 4 and 10 months, respectively （P=0,052）. The median overall survival was 5, 6 and 23 months, respectively （P=0.164）. The median progression-free survival was.3 and 10 months in the grade 0-2 and 3 skin rash groups （P=0.036）. The median overall survival was 6 and 23 months, respectively （P=0.073）. Conclusion： Skin rash bears relation to the response rate of erlotinib in patients with advanced non-small cell lung cancer. Progressionfree survival is better in the grade 3 skin rash group than other groups.